Comparing the Overall Efficacy of Endoscopic Ultrasound Fine Needle Aspiration Versus Fine Needle Biopsy in the Diagnosis of Solid Lesions: A Multicenter, Randomized Clinical Trial
Sponsor study identifier
interventional
400
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to determine if fine needle aspiration or fine needle biopsy is more efficacious and cost-effective than the other while maintaining diagnostic accuracy in the setting of solid gastrointestinal lesions.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
May 25, 2012
Actual (reported)October 2, 2012
Actual (reported)December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of needle passes needed to obtain a pathologic diagnosis.
Within 1 week of study enrollment
Diagnostic yield, defined as percentage of cases with a diagnostic biopsy sample, between FNA and FNB.
By three months post-op in the pathology report
Visible core specimens obtained and its correlation to obtaining a diagnostic sample.
During the intervention itself
Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a standard FNA needle
Endoscopic ultrasound guided needle tissue acquisition: Tissue acquisition using a new Core needle (Procore; Fine Needle Biopsy).
Endoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
ASGE Standards of Practice Committee; Gan SI, Rajan E, Adler DG, Baron TH, Anderson MA, Cash BD, Davila RE, Dominitz JA, Harrison ME 3rd, Ikenberry SO, Lichtenstein D, Qureshi W, Shen B, Zuckerman M, Fanelli RD, Lee KK, Van Guilder T. Role of EUS. Gastrointest Endosc. 2007 Sep;66(3):425-34. doi: 10.1016/j.gie.2007.05.026. Epub 2007 Jul 23. No abstract available.
Gress FG, Hawes RH, Savides TJ, Ikenberry SO, Lehman GA. Endoscopic ultrasound-guided fine-needle aspiration biopsy using linear array and radial scanning endosonography. Gastrointest Endosc. 1997 Mar;45(3):243-50. doi: 10.1016/s0016-5107(97)70266-9.
Satish Nagula, MD
Stony Brook University
First Submitted
May 25, 2012
First Posted
October 2, 2012
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2014
Estimated (date passed)Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle
Frequency of adverse side effects.
Three months post-op
Contact the study team to confirm eligibility.
Wiersema MJ, Vilmann P, Giovannini M, Chang KJ, Wiersema LM. Endosonography-guided fine-needle aspiration biopsy: diagnostic accuracy and complication assessment. Gastroenterology. 1997 Apr;112(4):1087-95. doi: 10.1016/s0016-5085(97)70164-1.
Iglesias-Garcia J, Dominguez-Munoz JE, Abdulkader I, Larino-Noia J, Eugenyeva E, Lozano-Leon A, Forteza-Vila J. Influence of on-site cytopathology evaluation on the diagnostic accuracy of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of solid pancreatic masses. Am J Gastroenterol. 2011 Sep;106(9):1705-10. doi: 10.1038/ajg.2011.119. Epub 2011 Apr 12.
Schwartz DA, Unni KK, Levy MJ, Clain JE, Wiersema MJ. The rate of false-positive results with EUS-guided fine-needle aspiration. Gastrointest Endosc. 2002 Dec;56(6):868-72. doi: 10.1067/mge.2002.129610.
Iglesias-Garcia J, Poley JW, Larghi A, Giovannini M, Petrone MC, Abdulkader I, Monges G, Costamagna G, Arcidiacono P, Biermann K, Rindi G, Bories E, Dogloni C, Bruno M, Dominguez-Munoz JE. Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study. Gastrointest Endosc. 2011 Jun;73(6):1189-96. doi: 10.1016/j.gie.2011.01.053. Epub 2011 Mar 21.
Camellini L, Carlinfante G, Azzolini F, Iori V, Cavina M, Sereni G, Decembrino F, Gallo C, Tamagnini I, Valli R, Piana S, Campari C, Gardini G, Sassatelli R. A randomized clinical trial comparing 22G and 25G needles in endoscopic ultrasound-guided fine-needle aspiration of solid lesions. Endoscopy. 2011 Aug;43(8):709-15. doi: 10.1055/s-0030-1256482. Epub 2011 May 24.
Nagula S, Pourmand K, Aslanian H, Bucobo JC, Gonda TA, Gonzalez S, Goodman A, Gross SA, Ho S, DiMaio CJ, Kim MK, Pais S, Poneros JM, Robbins DH, Schnoll-Sussman F, Sethi A, Buscaglia JM; New York Endoscopic Research Outcomes Group (NYERO). Comparison of Endoscopic Ultrasound-Fine-Needle Aspiration and Endoscopic Ultrasound-Fine-Needle Biopsy for Solid Lesions in a Multicenter, Randomized Trial. Clin Gastroenterol Hepatol. 2018 Aug;16(8):1307-1313.e1. doi: 10.1016/j.cgh.2017.06.013. Epub 2017 Jun 15.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 19, 2014
Record last verified: 2014-11
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